FDA panel says "no" to Targanta's oritavancin

USA-based Targanta Therapeutics' stock plummeted by 83% to $6.40 per share after the firm failed to receive a recommendation for its oritavancin from a Food and Drug Administration panel.

The Anti-Infective Drugs Advisory Committee voted 10 to eight that Targanta's data did not demonstrate the safety and effectiveness of the drug in the treatment of complicated skin and skin structure infections. The board is the same that recommended the approval of Theravance's similar agent telavancin (Marketletter November 24).

Chief executive Mark Leuchtenberger said: "we obviously are disappointed with the recommendation of the Advisory Committee, but we firmly believe that oritavancin's safety profile to-date and its unique pharmacokinetic profile confirm its potential to change treatment paradigms in cSSSI and other serious bacterial infections. We will continue our discussions with the FDA as it completes its review of oritavancin." The FDA's target date for making its decision is December 8.